340B Program Omnibus Guidelines

340B Mega Guidance Withdrawn and Sent Back to HHS

340B Mega Guidance Withdrawn and Sent Back to HHS

In a move that should surprise no one, the Office of Information and Regulatory Affairs (OIRA) announced that the 340B Program Omnibus Guidelines, aka the 340B Mega Guidance, was withdrawn on January 30th. The proposed rule, which was released in draft form in August  2015, was widely expected to be finalized last December. As a unit of OMB, OIRA speaks directly for President Trump's executive branch.